Quality Validation Specialist/Senior Specialist

Quality Validation Specialist

TerraPower Isotopes (TPI) is seeking an experienced Quality Validation Specialist to support Ac-225 production at the Everett manufacturing facility. The Quality Validation Specialist will play a critical role in establishing, implementing, and maintaining validation programs for radiopharmaceutical manufacturing operations in alignment with Good Manufacturing Practices (GMP), regulatory guidelines (FDA Title 21 CFR 210/211 and ICH Guidance), radiation safety, and company policies.

• Design and build validation lifecycle programs, including policies, master plans, templates, and procedures
• Develop and maintain Validation Master Plans (VMPs) aligned with GMP and radiopharmaceutical regulatory expectations
• Establish risk-based validation approaches suitable for scaling operations
• Lead and execute IQ/OQ/PQ activities for manufacturing equipment, hot cells, cleanrooms, and critical utilities
• Cook
• Coordinate validation activities with Engineering, Operations, QC and Radiation Safety teams
• Perform data analysis, deviation management, and validation summary reporting
• Support validation of computerized systems used in GMP manufacturing and quality systems (e.g., QMS, LIMS)
• Apply risk-based CSV principles in alignment with GAMP 5 and 21 CFR Part 11
• Support deviation investigations, CAPAs, and change management related to validated systems
• Ensure site validation practices align with FDA, EU GMP, ICH, and radiopharmaceutical-specific guidance
• Support internal audits and regulatory inspections
• Balance Quality requirements with safety, such as radiation safety, in all Quality initiatives

Qualifications and Skills

• Bachelor's degree in a life sciences discipline or a related field (or equivalent qualification through experience)
• Minimum 7 years of validation or quality experience in a GMP-regulated pharmaceutical or radiopharmaceutical environment under cGMP requirements
• Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma, or project management training/certification is a plus
• Demonstrated experience working within Quality Systems (compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance) and providing collaborative customer support
• Hands-on experience executing equipment, facility, or process validation
• Strong understanding of GMP, FDA regulations, and validation lifecycle principles
• Proven ability to work independently in fast-paced or startup environments
• Demonstrated experience in Computer System Validation (CSV), including validation of GxP electronic systems in accordance with GAMP 5 and 21 CFR Part 11 requirements
• Strong attention to detail, with the ability to interpret federal regulations, guidance, and standards. Incorporate relevant requirements into TPI documentation and provide guidance to personnel regarding compliance
• Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities
• Strong troubleshooting, analytical, and problem-solving skills, such as those developed in fast-paced environments including the military, and other nuclear or radiopharmaceutical environments is highly preferred
• The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork

Job Functions

• Motor Abilities: Sitting for extended periods, bending/stooping, grasping/gripping, fine motor control (hands)
• Physical exertion and/or requirements: Minimal, with ability to safely lift up to 25 pounds
• Repetitive work: Prolonged
• Special Senses: Visual and audio focused work
• Work Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of >8 hours/day
• Travel required 0-10%